Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252122
Status:
TERMINATED
Last Update Posted:
2009-03-13
First Post:
2005-11-09
Brief Title:
Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
A Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease
Status:
TERMINATED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was very slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this pilot study is to provide a preliminary assessment of the feasibility and efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease who are admitted to the hospital with severe acute pain crisis and who have been resistant to intravenous narcotics
Detailed Description:
It is often difficult to manage acute painful crisis in patients with sickle cell disease The usual management of these crises relies on hydration administration of oxygen and narcotics like morphine A select group of patients for unknown reasons does not respond to this management and these patients often require prolonged use several days of intravenous narcotics Narcotics have proven to be ineffective in controlling this type of pain and can cause multiple side effects sedation vomiting respiratory depression We propose to administer intravenous ketamine in this group of patients who are resistant to intravenous narcotics Ketamine has been proven to be effective in controlling pain in multiple clinical situations However there are no data in the literature describing its use in patients with sickle cell disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None